Registry to Assess Long-term Outcome in HIV Subjects Who Participated in Phase 2 and 3 Clinical Trials Involving Vicriviroc (Study P04999)

HIV Infections Clinical Trial

— COVER  

Official title:

COVER - Continuing Observation After Vicriviroc (VCV) Exposure Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705419
• Other study ID #: P04999
• Status: Completed
• Phase: N/A
• First received: June 23, 2008
• Last updated: February 4, 2015
• Start date: July 2007
• Est. completion date: September 2010

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Nonrandomized, prospective, observational, multi-site registry to assess long-term safety, clinical outcome, deaths, and evolution of viral tropism in HIV subjects who completed or discontinued participation in Phase 2 or 3 clinical trials involving vicriviroc. Subjects will be followed for up to 5 years.

Description:

A non-probability sampling method will be used. Subjects will be requested to enroll in the registry after having completed or discontinued participation in a Phase 2 or 3 study involving vicriviroc.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects must have participated in a Phase 2 or 3 study involving vicriviroc, and must have received, but are no longer receiving study medication.

Exclusion Criteria:

• Unwillingness to participate in the registry or give informed consent.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Vicriviroc maleate
Follow-up for subjects who previously received 30 mg tablet administered once daily according to the parent protocol.
• Vicriviroc maleate
Follow-up for subjects who previously received 20 mg tablet administered once daily according to the parent protocol.
• Placebo
Follow-up for subjects who previously received placebo tablet administered once daily according to the parent protocol.
• Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg
Follow-up for subjects who previously received active control consisting of emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg combination tablet administered once daily according to the parent protocol.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of malignancies, AIDS-defining events, other clinical events of importance, and death.		Information regarding clinical outcome will be collected every 6 months. Deaths will be collected on an ongoing basis.	Yes
Secondary	Incidence of change in plasma viral tropism, time to change in plasma viral tropism, and change in HIV RNA and CD4+ counts, if available.		Every 6 months.	No